Duns Number:002054419
Device Description: 0.2 micron Intravenous Filter for 96 Hour Use with Luer-Lock Outlet Port
Catalog Number
ELD96NT
Brand Name
Pall Posidyne® ELD Filter
Version/Model Number
ELD96NT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K850825,K850825
Product Code
FPB
Product Code Name
Filter, infusion line
Public Device Record Key
f59fa397-0cab-4a26-becd-c740b7ac22d8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 01, 2016
Package DI Number
30636207000126
Quantity per Package
40
Contains DI Package
00636207000125
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |